Trial Information

A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery

The CSF provides a liquid cushion for the brain and spinal cord. The dura holds in the CSF.
In order to do spinal surgery, the doctor will cut an opening in the dura. At the end of
surgery, the dura must be sealed in order to keep the CSF from leaking out. The doctor will
close the dura with stitches and also a piece of tissue taken from another place on your
body, to help close the opening. Other standard sealant methods have included the use of
Oxicel, Gelfoam, or fibrin glue, but these methods were not designed for closing the dura.

Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in this
study. Your doctor will see you within 30 days before your operation. At this visit, your
medical history will be recorded, and you will be asked questions about any other operations
you have had in the past. You will have a complete physical exam, including measurement of
vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and
weight. You will have a sample of your blood (about 2 tablespoons) collected for kidney and
liver function tests to make sure they are functioning properly. You will also be asked to
fill out 2 questionnaires about your health, daily activities, and back pain. The
questionnaires will take about 20 to 30 minutes to complete. Women who are able to have
children must have a negative blood pregnancy test.

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to one of 2 treatment groups. Participants in one group will
receive the Spinal Sealant. You have a 2 out of 3 chance of being randomly assigned to the
spinal sealant group. Participants in the other group will receive other standard methods
such as the closing of the dura with stitches. However, you will not know which one of the
two treatments you receive. Also, (if needed) a piece of your muscle, fat, or other soft
tissue may be taken from another place on your body to help seal the opening. Doctors may
also use Oxicel, Gelfoam, or fibrin glue to help with the sealing of the dura .

After your already scheduled spinal surgery, your doctor will try to close the opening in
the dura, which may be done with stitches alone or, if needed, stitches and a piece of your
muscle, fat, or other soft tissue taken from another place on your body. After this try, if
there is still some CSF leaking from the dura, you will be assigned to one of the 2 groups
for treatment. If you do not have a CSF leak that needs treatment, you will not be able to
take part in this study, and you will not have to come back for any study visits.

Participants assigned to the first group will receive treatment with the Spinal Sealant,
which will be sprayed over their stitches to close the opening in their dura. The Spinal
Sealant is made of 2 plastic-type liquids. When mixed together, a gel is formed that is
mostly made up of water. The gel looks and feels sort of like a soft contact lens. After the
doctor tries to seal the opening in the dura, the Spinal Sealant is then sprayed over the
stitches. It acts like a thin, stretchy covering to help stop the CSF from leaking out
through the stitches until the area has properly healed on its own. It is blue-colored, so
that the doctor can see where it has been sprayed. Within 1 to 2 months, the gel is
naturally broken down by the body and is removed through the urine.

Participants assigned to the second group will be treated with the doctor's choice of other
standard treatments to close the opening in their dura. You will not know which group you
were assigned to until after the end of your study participation (about 90 days).

While you are still in the hospital (within 7 days after your operation), you will have a
physical exam, and your doctor will do a clinical test to check for any CSF leaks. Also, you
will have a sample of your blood (about 2 tablespoons) drawn for kidney and liver function
tests.

For follow-up, you will be seen by your doctor at about 30 days and again at about 90 days
after your operation. It will be very important for you to return to see your doctor at your
scheduled follow-up visits, even if you are feeling fine. At the follow-up visits, your
doctor will perform a physical exam and check to see how your dura wound is healing and if
there is any CSF leakage. You will have a sample of your blood (about 2 tablespoons)
collected for kidney and liver function tests. You will also be asked to fill out 2
questionnaires about your health, daily activities, and back pain. The questionnaires will
take about 20 to 30 minutes to finish.

Your participation in this study will be over after your 90-day follow-up visit.

THIS IS AN INVESTIGATIONAL STUDY. The Spinal Sealant has been authorized by the FDA for use
in research only.

About 158 patients will take part in this multicenter study. Between 15 to 20 participants
will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patient is between 18 and 75 years of age.

2. Patient is scheduled for a spinal procedure that entails a dural incision.

4. Patient, or authorized representative, has been informed of the nature of the study,
and has provided written informed consent, approved by the appropriate Institutional
Review Board (IRB) of the respective clinical site.

5. Intraoperative Criteria: Presence of non-watertight closure, either spontaneously or
upon Valsalva maneuver to 20-25 cm H20 for 5-10 seconds.

Exclusion Criteria:

1. Patient has active spinal and/or systemic infection.

2. Patient will require additional spine surgery within the study time period.

3. Patient has had a previous spinal surgery involving dural exposure and/or entry at
the same level(s) as the study procedure.

5. Patient is participating in a clinical trial of another investigational device or
drug.

6. Patient with creatinine > 2.0 mg/dL.

7. Patient with total bilirubin > 2.5 mg/dL.

8. Pregnant or breast-feeding females or females who wish to become pregnant during the
length of study participation.

9. Patient has been treated with chronic steroid therapy unless discontinued more than 6
weeks prior to surgery (standard perioperative steroids are permitted). For purposes
of this protocol, chronic steroid therapy is defined as greater than 4 weeks.

10. Patient has documented history of significant coagulopathy with a PTT > 35 sec, PT/
INR >1.2, receiving aspirin, or NSAIDS at the time of surgery. Note: Patients who are
receiving cardiovascular prophylaxis are not excluded.

11. Patient is receiving warfarin or heparin at the time of surgery (including analogs).

12. Patient has a diagnosed and documented compromised immune system and/or autoimmune
disease.

13. Patient has had chemotherapy treatment within 6 months prior to, or planned during
the study (until completion of last follow-up evaluation).

14. Patient has had prior radiation treatment to the surgical site or has planned
radiation therapy within 30 days post procedure.

15. Patient has a known malignancy or another condition with prognosis shorter than 6
months.

16. Patients has a documented history of uncontrolled diabetes.

17. The investigator determines that the patient should not be included in the study for
reason(s) not already specified.

18. Intraoperative Criteria: Patient requires use of a synthetic or non-autologous
duraplasty material.

19. Intraoperative Criteria: Patient has a gap of greater than 2mm remaining after
primary dural closure.

20. Patient has undergone laminoplasty decompression.

21. Patient has undergone a Chiari Malformation procedure that does not entail a dural
incision at or below the C1 level.

22. Investigator determines that participation in the study may jeopardize the safety or
welfare of the patient.

23. Patient has undergone a syringomyelia procedure where the shunt is not placed in the
subarachnoid position.

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